Stöckert 3T Heater-Cooler Devices
Patients in the Pittsburgh and surrounding Ohio Valley areas who had open-heart surgery and then suffered a serious infection may be eligible to recover medical costs and other damages through a personal injury lawsuit.
LivaNova PLC, formerly Sorin Group Deutschland GmbH, recently revealed that their 3T Heater-Cooler Devices (HCDs)—which are frequently used during open-heart surgeries to maintain the proper body temperature for patients—could be the source of a number of reported nontuberculous mycobacterium (NTM) infections. These infections can cause serious illness and even death.
We are now learning that the devices were contaminated with Mycobacterium chimaera (M. chimaera), a type of NTM, at the manufacturing site. When the devices were then used in surgery, there was a risk that the airborne bacteria could spread throughout the room and an infection could then be contracted by the patient through their open surgical wounds.
According to The Washington Post, in just the past year, at least 28 cases of M. chimaera infections have been identified at hospitals in Iowa, Michigan, and Pennsylvania. More have been reported in patients in Europe.
On October 13, 2016, the Food and Drug Administration (FDA) released a safety communication warning that surgery with these devices had been linked with M. chimaera infections. They advised doctors and hospitals to immediately remove any of these devices that have tested positive for the bacteria from their facilities, and to consider limiting the use of all of these devices until the manufacturer found a way to mitigate the risks of patient infection.
Heater-Cooler Devices Increase Risk of Infections
The New York Times recently reported that at least 12 patients at a Pennsylvania hospital were infected by an HCD used during their open-heart surgeries in 2015. A field investigation by the Pennsylvania Department of Health, with help from the Centers for Disease Control and Prevention (CDC), determined that there was an association between the infections (caused by the M. chimaera bacteria) and exposure to contaminated Stöckert 3T HCDs.
Once they figured this out, they notified 1,300 potentially exposed patients of the potential risk.
Other infections were reported in Iowa. Investigators conducted subsequent tests, including whole genome sequencing on isolates from 11 patients, and three tests on five HCD devices:
- swabs from the interior of the device;
- samples of water drained from the devices; and
- air samples collected while a device was operating
The results of these tests suggested that the Stöckert 3T HCDs were contaminated with M. chimaera. Investigators noted that a recent report from Germany indicated that M. chimaera from HCDs from three different European countries were almost identical to samples obtained from the LivaNova PLC manufacturing site.
The CDC reported that although thousands of patients in the U.S. who may have been exposed to the bacteria have already been notified, the actual number at risk may be much higher. Over 250,000 cardiopulmonary bypass procedures (such as open-heart surgery) are performed each year, and Stöckert 3T HCDs represent about 60 percent of the devices use in these surgeries.
What are Heater-Cooler Devices?
Heater-cooler devices (HCDs) are medical devices that use water to help regulate patients during open heart surgery. Procedures include open-heart surgery, coronary artery bypass surgery, heart valve surgery, and surgery for lung cancer.
These devices have water tanks that provide temperature-controlled water to external heat exchangers or warming/cooling blankets through closed circuits. Though the water never comes into contact with the patient, the devices have fans and exhaust vents.
There is the potential for contaminated water to enter other parts of the device and aerosolize, and that contaminated air can then circulate into the surgery room where it can potentially infect a patient going through cardiothoracic surgery.
In September 2016, the Seattle Times reported that bacteria that cause Legionnaires’ disease (which is a serious form of pneumonia) had been detected in HCDs used during open-heart surgeries. Three of the machines tested positive for the bacteria, and at least four patients were diagnosed with the disease. Two of the patients died.
Though we may be exposed to many types of bacteria in our daily lives, they usually don’t affect us because our immune systems render them harmless. They can be particularly dangerous, however, during open-heart surgery because patients are in a particularly vulnerable state. Inner organs are exposed to the air, and the patients may also have weakened immune systems.
Adding to the danger is that once the machines are contaminated, it can be difficult to make them safe again. HCDs can be difficult to clean because bacteria can form a biofilm on the machine that is resistant typical disinfectants.
The FDA released recommendations for cleaning and disinfection of the devices in October 2015, and advised hospitals not to use tap water for any reason since it could introduce NTM organisms.
What are Stöckert 3T Heater-Cooler Devices?
Currently, there are about 2,000 Stöckert 3T HCDs in the U.S. Manufactured by LivaNova PLC, formerly Sorin Group Deutschland GmbH. These devices have been available since 2006.
The manufacturer advertises the devices as efficient heating and cooling machines. In October 2016, however, in response to the FDA and CDC warnings, the company released a “field safety notice update” warning surgeons and hospitals of potential risks associated with the use of the machines.
They acknowledged the CDC’s tests that showed a “genetic similarity between both patient and heater cooler strains of the NTM bacteria M. chimaera isolated in Iowa and Pennsylvania.” They added that they were “continuing to analyze” the data, would work with the CDC and the FDA to facilitate their recommendations for reducing risk, and would “develop solutions to further mitigate the potential risk of NTM contamination.”
The company has been aware of infections and even deaths linked to these devices since no later than 2014. Consumer Reports noted that at Greenville Memorial Hospital in South Carolina, officials identified at least 15 patients that were diagnosed with rare infections after open heart and lung operations. Four of them died. An investigation traced the infections to the HCDs used in the operations.
Similar incidents have been reported in Iowa, Michigan, and Pennsylvania. Between January 2010 and February 2016, the FDA received 180 incident reports related to HCDs around the world. These reports include 16 U.S. hospitals across 10 states, where at least 45 patients were infected and at least nine died.
Heater-Cooler Devices Can be Contaminated with Bacteria
NTM organisms are naturally occurring and are found in water and soil. They are not usually dangerous to humans unless they’re inhaled or if they enter the body in another way, such as during surgery.
Most people who are exposed to NTM organisms clear them from the lungs naturally and don’t suffer infections, but in people with weak immune systems, or who undergo these types of surgeries, the risk of infection is greater.
In a 2016 study, researchers identified HCDs (also called “heating-cooling units” or HCUs) as the source of M. chimaera that caused surgical site infections in patients. Their results confirmed “airborne transmission of M. chimaera aerosols from a contaminated HCU to an open surgical field despite ultraclean air ventilation.”
In another 2016 study, researchers found a link between M. chimaera samples taken from several European infected patients, from the HCUs used during their procedures, and from environmental samples from Sorin’s HCU production and servicing facility in Germany. Researchers concluded that at least some of the M. chimaera infections may have been caused by HCUs that were contaminated at the manufacturing site.
So far, a Seattle hospital has reported is the only area to report a connection between HCDs (made by another manufacturer) and Legionnaire’s disease, but patient advocates warn that there may be other similar cases. Though most have been connected to the NTM M. chimaera, it seems that these devices are difficult to clean, which means they may be a source of potential contamination with other bacteria as well.
FDA Tracks Problem of Stöckert 3T Heater-Cooler Device Infections
The FDA has been following the issue of HCD-related infections for over a year, now. Here’s a summary of their activity relating to these devices:
- October 2015: The FDA released a safety communication warning that the use of HCDs was associated with NTM infections, “primarily in patients undergoing cardiothoracic surgical procedures.” They added that in some cases, patients presented with infections “several months to years after their surgical procedures.” They recommended that facilities and staff strictly adhere to cleaning and disinfection instructions, and to use only sterile water to rinse, fill, or refill the tanks.
- December 2015: The FDA issued a warning letter to the manufacturer after inspections of several of their facilities revealed significant issues, including quality system and premarket clearance violations. They also placed an import alert on the devices to restrict how many could come into the U.S.
- June 2016: The FDA released an updated safety communication warning surgeons, hospital staff, and patients of potential infections associated with the use of the Stöckert 3T HCD. This time, they revealed that testing by the manufacturer back in August 2014 found chimaera on the production line and water supply at the 3T manufacturing facility. In response, the company added cleaning and disinfection procedures to the production line in September 2014. Samples taken in June 2015 showed no bacteria contamination. The FDA recommended that facilities that purchased and used the 3T prior to September 2014 be aware that the units may have been shipped from the factory contaminated with M. chimaera.
- October 2016: The FDA released another safety communication, warning that health care facilities should take additional steps to help mitigate the risk of infections associated with 3T HCUs. Specifically, they recommended that any facility with devices manufactured prior to September 2014 should “strongly consider transitioning away from the use of these devices for open-chest cardiac surgery until the manufacturer has implemented strategies for these devices to mitigate the risks of patient infection.”
- Ongoing: The FDA continues to evaluate infections associated with heater-cooler devices, primarily in patients going through open-heart surgery. They are also working to determine the cause of these infections, one of which may be the heater-cooler design.
Types of Injuries Associated with Stöckert 3T Heating-Cooling Devices
Most infections show up rather quickly, but that’s often not the case with HCD-related infections.
- chimaera is a slow-growing bacteria, which means that it can be present inside a patient for months and even years without detection. The CDC warns that patients who have been exposed through open-heart surgery can “develop general and nonspecific symptoms that can often take months to develop.”
That means it’s important for doctors and patients to be on the lookout for potential symptoms. Otherwise a diagnosis can be missed or delayed, sometimes for years. During that time, the bacteria continue to grow, so that when the infection is finally detected, it may be more difficult to treat.
So far, there is no blood test or other type of medical test to determine for sure that a person has been exposed. Only a laboratory culture is able to confirm a diagnosis, but it can take months for the bacteria to grow enough for a culture to be usable.
Patients who have gone through open-heart surgery should notify their doctor immediately if they experience any of the following symptoms:
- Night sweats
- Muscle aches
- Weight loss
- Unexplained fever
- Difficulty breathing
- Persistent cough or cough with blood
Other infection-related complications that can occur up to four years after surgery include:
- Surgical site infection
- Endocarditis (inflammation of the inner lining of the heart)
- Hepatitis (inflammation of the liver)
- Renal insufficiency (kidney problems)
- Osteomyelitis (inflammation in the bone)
- Splenomegaly (spleen enlargement)
- Pancytopenia (deficiency of red and white blood cells and platelets at the same time)
- Bacteremia (bacteria in the blood)
Stöckert 3T Heater-Cooler Device Lawsuits
In February 2016, two York County residents who had gone through heart surgery at WellSpan York Hospital filed a new multimillion-dollar federal class-action lawsuit in Pennsylvania. They named LivaNova PLC, the manufacturer of the Stöckert 3T Heating-Cooling devices used in their surgeries as defendant.
The plaintiffs filed the lawsuit after receiving a letter alerting them that they may have been exposed to NTM bacteria during their surgeries. They seek damages on behalf of themselves and other patients who were exposed. In their complaint, they allege that eight people who went through open-heart surgery at WellSpan were diagnosed with NTM infections, and that five of those died. They add that the CDC has linked the infections to the Stöckert 3T Heating-Cooling devices.
If you or a loved one went through cardiothoracic surgery in which a Stöckert 3T HCU was used and then developed a serious infection or were informed of exposure to potentially deadly bacteria, you may be eligible to file a Stöckert 3T Heater-Cooler device lawsuit.
Patients may be unaware of which device was used in their surgery. Chaffin Luhana provides consultations and case evaluations to help determine which device was used, and whether patients may have a case against LivaNova PLC.
Call today for a free and confidential case evaluation at 1-888-316-2311. Chaffin Luhana Pittsburgh attorneys represent individuals in West Virginia, Western Pennsylvania, and Eastern Ohio.